Associate Manager, Quality Compliance

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The Associate Manager, Quality Compliance supports the development, maintenance, and continuous improvement of the Quality Management System (QMS) at the Braintree site. This role provides leadership for key compliance programs—including CAPA, Nonconformance, Internal Audit, Quality Management Review, and Quality Metrics—and plays a critical part in ensuring ongoing regulatory compliance across site operations. The Associate Manager will also support external audit readiness and execution, including leadership of backroom activities, coordination of documentation, and engagement with subject matter experts.

While this role has no direct reports, it provides day‑day guidance to site Quality Compliance personnel and partners closely with cross‑functional teams to ensure consistent, compliant processes.

• Support the effective operation of the site Quality Management System (QMS), ensuring compliance with internal procedures, current Good Manufacturing Practices, and applicable regulatory requirements.
• Lead the CAPA program, including CAPA Review Board (CRB) coordination, review of investigations, action planning, and overall phase execution.
• Support the Nonconformance and Internal Audit programs, including planning, execution, follow‑up, and documentation of audit responses and results.
• Prepare and coordinate materials for Quality Management Review (QMR), including site metrics, trend analyses, and reporting against the Quality Objectives.
• Provide leadership for backroom activities during external audits (e.g., Notified Body audits, FDA inspections), including document management, SME coordination, and response strategies.
• Prioritize activities and projects to ensure timely completion of compliance obligations and remediation commitments.
• Lead or support quality improvement initiatives and cross‑functional compliance projects as assigned.
• Develop and maintain compliance documentation, including audit responses, CAPA records, metrics, and QMS summaries.
• Serve as a resource to CAPA, NC, and Audit personnel, providing coaching and guidance to strengthen understanding of quality system requirements.
• Support escalation, communication, and reporting of quality system risks or concerns to site leadership.
• Perform other duties as assigned.

• Bachelor’s degree in Engineering, Life Science, or related field with 5+ years of experience in Quality Assurance, Quality Compliance, or a related discipline within the medical device or similarly regulated industry
  • Master’s degree with 3+ years of experience, or
  • Doctoral degree with 0–2 years of experience may be considered
• Working knowledge of applicable regulations and standards, including:
  • 21 CFR 820, 803, 806;
    Part 11;
    Part 4
  • ISO 13485
  • MDSAP requirements
  • Global regulatory expectations (ANVISA, Health Canada, TGA, EU, etc.)
• Demonstrated experience with CAPA processes, investigational techniques, root cause analysis, and verification of effectiveness practices.
• Experience supporting external audits, including backroom coordination; experience with FDA inspections strongly preferred.
• Strong written and verbal communication skills, with proven ability to draft and review regulatory and quality system documentation.
• Familiarity with quality metrics, data analysis, and trend identification.
• Strong critical thinking, problem solving, and analytical abilities.
• ASQ certifications (e.g., CQA, CQE) are a plus.
• Ability to work cross‑functionally, influence without authority, and support a culture of quality and compliance.

$94,300.00 – $ USD Salary. Salary ranges are determined by role, level, and location. Individual pay is determined…